Australia TGA ARTG record

Radiology Workstation Software - Radiology picture archiving and communication system application software

Australia TGA ARTG Registered Device · Fujifilm Australia Pty Ltd · Fujifilm Healthcare Americas Corporation · Class IIa · Started June 25, 2019

Good Name: Fujifilm Australia Pty Ltd - Radiology Workstation Software - Radiology picture archiving and communication system application software

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: June 25, 2019
Effective Date: June 25, 2019

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: Fujifilm Healthcare Americas Corporation
Country: United States of America
Address: 81 Hartwell Avenue Suite 300 Lexington, Massachusetts, 02421

Intended purpose

Synapse Cardiovascular provides the functionality for viewing, measuring, analyzing, archiving, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers.

About this record

Access comprehensive regulatory information for Radiology Workstation Software - Radiology picture archiving and communication system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Healthcare Americas Corporation in United States of America. The device registration started on June 25, 2019.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.